PMA P810006S074

Device: COLLASTAT INSTAT ABSORABLE COLLAGEN HOMESTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S074
Product code: LMF
Decision date: 2016-12-07
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Clearance for an Electronic Chart Recorder (E-Chart System) for the Hull 2 and Hull 3 Lyophilizer (freeze dryer). The E-Chart system provides visualization, data acquisition, trouble shooting, and trending capabilities of the Hull 2 and 3 lyophilization process to maintenance and engineering personnel. This system is meant to supplement but not replace the current Yokogawa paper chart recorders on these lines, which collect and plot lyophilization process parameters but have no storage or information transfer capabilities.

Current openFDA PMA Record#

Device: COLLASTAT INSTAT ABSORABLE COLLAGEN HOMESTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S074
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2016-12-07
Decision code: OK30
Date received: 2016-11-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Clearance for an Electronic Chart Recorder (E-Chart System) for the Hull 2 and Hull 3 Lyophilizer (freeze dryer). The E-Chart system provides visualization, data acquisition, trouble shooting, and trending capabilities of the Hull 2 and 3 lyophilization process to maintenance and engineering personnel. This system is meant to supplement but not replace the current Yokogawa paper chart recorders on these lines, which collect and plot lyophilization process parameters but have no storage or information transfer capabilities.